Alzheimer's Disease Clinical Trials

Find Alzheimer's Disease Clinical Trials Near You

Novel Methods for Clinical Trials in Dementia and Cognitive Decline

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to demonstrate potential improvements in clinical trial methods relating to dementia and cognitive decline. The main questions it aims to answer are: * Can an intervention's outcome be better assessed by a latent variable (δ) integrating cognitive performance with functional status? * Can latent biomarkers of δ guide the selection of an intervention that will modulate dementia severity? * Can a latent variable, derived from information collected remotely from caregivers, preselect subjects most likely to respond to the intervention? * Is the effect of the intervention in fact medicated by changes in the targeted biomarker? In this case, the biomarker will be a latent variable derived from several proteins measured in blood (i.e., so-called adipokines). The intervention will be donepezil, a medication approved for the treatment of Alzheimer's Disease, but only recently associated with adipokine changes. Participants with cognitive impairment and their caregivers will be interviewed by telephone and those newly prescribed donepezil by their provider for cognitive impairment will be recruited and enrolled. On the basis of the caregiver's report, the cognitively impaired subjects will be assigned to two groups based on a prediction of their response to donepezil. Researchers will compare those groups to see if dementia severity, as measured by δ, improves in predicted responders, and whether the change in the d-score is mediated by changes in adipokines.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Maximum Age: 100
Healthy Volunteers: f
View:

• Ambulatory outpatient volunteers with competent informants. Competent informants are cognitively normal individual(s) who interacts with the person on a regular (at least 5 or more hours/week) basis and in the opinion of the PI can provide adequate collateral information on the participant's memory and cognitive status.

• Aged 65-100 years

• Clinical diagnosis of AD, or MCI.

• Capacity to give informed consent. If a patient is found to clinically decline during the course of the study and no longer able to provide consent, continued participation will be evaluated by the PI on a case-by-case basis.

• GDS score (15 item) ≤ 8

• No significant visual or hearing impairments

• A standardized dECog score between 1.5 and 3.5 relative to ADNI's cohort.

Locations
United States
Texas
Univeristy of Texas Health Science Center at San Antonio (UTHSCSA)
RECRUITING
San Antonio
Contact Information
Primary
Samuel Guess
guesss@uthscsa.edu
210 567 8133
Backup
Floyd Jones
JONESFA@uthscsa.edu
210 450 3158
Time Frame
Start Date: 2024-08-05
Estimated Completion Date: 2028-11-30
Participants
Target number of participants: 200
Treatments
Other: Predicted Responders
Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.
Other: Predicted Non-Responders
Group assignment determined by a response predictor algorithm derived from remotely acquired caregiver reports of cognitive performance. The donepezil administered during the study is prescribed by the subject provider as standard of care.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Aging (NIA)
Leads: The University of Texas Health Science Center at San Antonio

This content was sourced from clinicaltrials.gov